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NCT Number: NCT02636504

Evaluation of Three Pulp Vitality Tests

The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location contact

Sahng G Kim, DDS, MS

PRINCIPAL_INVESTIGATOR

About this study

Prior to starting any endodontic treatment, it is essential to determine the vitality of the tooth in question. Vitality of a tooth is defined as the presence of blood flow into the tooth. The vitality status of a tooth will affect the success of endodontic treatment, and therefore plays an important role in treatment planning. Two established methods of determining vitality are electric pulp tests and cold tests. However, both these methods have drawbacks. Both methods use the presence of sensory feedback in the tooth as a predictor of tooth vitality. This can lead to errors because blood flow and nerves in the tooth may be lost at different times, resulting in false-positive and false-negative responses. Both are subjective and patient-dependent, relying on the patient to indicate when pain is felt. In addition, studies have suggested that electric pulp testing and cold tests are not as reliable in immature teeth, teeth undergoing orthodontic movement, traumatized teeth, and teeth with significant secondary dentin. Laser Doppler flowmetry is a technique that utilizes the Doppler principle to determine blood flow. It has been used widely in the medical field to measure blood flow in the skin. Some studies have also shown good results in measuring blood flow in the pulp of teeth. The objectives of this study are to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of laser Doppler flowmetry in determining the vitality of teeth and comparing with those of electric pulp testing and cold testing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Criteria for inclusion in the study will be that the individual has teeth that require endodontic treatment and patient is willing to undergo two additional vitality tests which will take about 20 minutes of additional time.

Exclusion criteria

  • No group of special subjects or vulnerable population is being targeted in this study.

Treatment and study plan

Laser Doppler Flowmetry

Device

Pulp vitality of teeth is tested with three pulp vitality testing including laser Doppler flowmetry, cold testing, and electric pulp testing.

Other names: Cold testing, Electric Pulp Testing

Primary outcomes

  1. The number of teeth showing the true positive, true negative, false positive, and false negative after pulp vitality testing

    Time frame: 1 year

    Patients who present to the endodontic clinic for a consultation visit prior to treatment. The patient will have three types of pulp vitality tests done on the tooth that is to receive endodontic treatment. The number of teeth that show the true positive, true negative, false positive, and false negative after pulp vitality testing will be measured. For example, a tooth that is diagnosed nonvital based on the pulp vitality testing will be confirmed when endodontic treatment is performed. If there is a discrepancy, it can be counted as false negative. When a tooth is diagnosed vital based on the pulp testing and confirmed to be vital, it can be counted as true positive. When a tooth is diagnosed vital based on the pulp testing and confirmed to be nonvital, it can be counted as false positive. When a tooth is diagnosed nonvital and confirmed novital, it is counted as true negative.

Study contacts

Contact information is provided by the study sponsor or research team.

Sahng G Kim, DDS, MS

CONTACT

[email protected]

212-305-2015

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 21, 2015
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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